This STTR Phase I Project will determine if uterine activity measured from the utero-cervico- vaginal wall can be a predictor for discerning Braxton Hicks (false) contractions and pathological (true) labor contractions in mid-gestation pregnancies. We will use a previously developed prototype to measure uterine activity from the utero-cervico-vaginal interface that has shown comparable results to abdominal electrohysterography (EHG). Published to have a high specificity, EHG's largest hurdle to commercialization is its low sensitivity for predicting preterm labor. Therefore, by bypassing the abdominal surface, we will increase the sensitivity of the technology and its likelihood for commercialization success. The device will be compared to an intrauterine pressure catheter (IUPC) and the tocodynamometer (TOCO) in fifteen mid-gestation ewes to validate the presence of uterine activity. We will deliver oxytocin intravenously to initiate contractions in th sheep until distinct contractions are detected, then the device, IUPC and TOCO will record all uterine activity simultaneously for two hours. When comparing the devices, the IUPC will be considered the control for contraction measurements. With the data acquired from these experiments, we will implement a novel methodology and investigate various frequency bands of the uterine activity signal to create an output that will aid physicians in determining if a presenting patient has Braxton Hicks contractions or pathological labor contractions. In analyzing the data, the frequency bands will be isolated with a band pass filter. And finally, obstetricians and nurses will be surveyed to confirm whether our presentation of the data is easy to understand. Upon successful completion of this STTR Phase I project, the technology will have the potential to reduce overtreatment and misdiagnosis rates of preterm labor and cervical incompetence, as well as to improve neonatal outcomes.
This project will advance uterine contraction monitoring in pregnant women to increase the effectiveness of antenatal surveillance. Compared to the current standard of care, we will detect even the faintest contractions by measuring electrical signals directly from the cervix and tell apart true contractions that lead to birth and false ones that do not. In the end, we will optimize a device and create a method that will potentially allow for timely interventions and a reduction in overtreatment.